Malaria vaccine trial shows the potentiating power of incremental progress

Med ◽  
2021 ◽  
Vol 2 (6) ◽  
pp. 635-636
Author(s):  
Brandon Wilder
Keyword(s):  
Malaria Vaccine ◽  
Vaccine Trial

The Ethics of End-of-Trial Obligations in a Pediatric Malaria Vaccine Trial: The Perspectives of Stakeholders From Ghana and Tanzania

2018 ◽  
Vol 13 (3) ◽  
pp. 258-269 ◽  
Author(s):  
Claire Leonie Ward ◽  
David Shaw ◽  
Evelyn Anane-Sarpong ◽  
Osman Sankoh ◽  
Marcel Tanner ◽  
...  
Keyword(s):  
Health Care ◽  
Health Care Services ◽  
Malaria Vaccine ◽  
Care Service ◽  
Health Care Service ◽  
Vaccine Trial ◽  
Health Indicators ◽  
Treatment Access ◽  
Post Trial ◽  
The Impact

This study explores stakeholder experiences and perspectives on end-of-trial obligations at the close of a phase II/III Pediatric Malaria Vaccine Trial (PMVT) [GSK/PATH-MVI RTS, S) (NCT00866619]. We conducted 52 key informant interviews with major stakeholders of an international multicentre PMVT in Ghana and Tanzania. The responses fell into four main themes: (a) Communicating End-of-Trial, (b) Maintaining Health Care Services, (c) Dissemination of Results, and (d) Post-Trial Access. Interviewee responses shared important practical experiences and insights that complement current thinking in the literature on research ethics guidance: (a) accompany end-of-trial communication with information on personal and family health care responsibilities, (b) establish public health indicators to measure the impact of research on a health care system, (c) design a gradual exit strategy with opportunities to address unplanned events, (d) endorse a principled approach of continuity of care when designing a health care service handover, and (e) devise an actionable post-trial treatment access pathway with diverse stakeholder representatives.

scholarly journals OC 8582 A PHASE IA/B STUDY TO ASSESS SAFETY AND IMMUNOGENICITY OF PLACENTAL MALARIA VACCINE CANDIDATE: PRELIMINARY RESULTS OF THE PRIMALVAC TRIAL

2019 ◽  
Vol 4 (Suppl 3) ◽  
pp. A14.3-A15
Author(s):  
Amadou Konate ◽  
Laura Richert ◽  
Arnaud Chêne ◽  
Jean-Philippe Semblat ◽  
Gwenaelle Roguet ◽  
...  
Keyword(s):  
Adverse Events ◽  
Burkina Faso ◽  
Malaria Vaccine ◽  
Clinical Laboratory ◽  
Placental Malaria ◽  
Safety Data ◽  
Vaccine Trial ◽  
Adult Women ◽  
Serious Adverse Events ◽  
Double Blind

BackgroundAdhesion of P. falciparum-infected erythrocytes (PEs) to placental chondroitin-4-sulfate (CSA) has been linked to severe placental malaria (PM) outcomes. Evidence strongly supports the VAR2CSA variant surface antigen mediating PEs CSA-binding phenotype as the leading candidate for a PM vaccine. This study was conducted to assess the safety and immunogenicity of 3 different dosages (20 µg, 50 µg and 100 µg) of the recombinant VAR2CSA protein (PRIMVAC), formulated with Alhydrogel or GLA-SE administered at days 0, 28 and 56.MethodsA randomised double-blind phase Ia/Ib dose-escalation vaccine trial was conducted in healthy adult women. Within 4 sequential cohorts, volunteers were randomised to 2 arms (PRIMVAC adjuvanted with Alhydrogel or GLA-SE) in the first phase conducted in France and then to 3 arms (PRIMVAC with Alhydrogel or GLA-SE or placebo) in Burkina Faso. Enrolled volunteers were observed for at least 1 hour following each vaccination then seen at 1 day and 7 days later for safety evaluations. Serious adverse events (SAE) were recorded throughout the study duration. Routine clinical laboratory safety analyses were performed prior to first injection and at each subsequent visit.ResultsA total of 68 subjects were recruited in the four study cohorts. No SAE was reported in any of the cohort A volunteers and enrolment in cohort B was started. A Data Safety Monitoring Board (DSMB) reviewed the safety data for cohorts A (20 µg) and B (50 µg) before the trial was initiated in Burkina Faso. The DSMB also reviewed the safety data in Burkina to authorise the progression from the cohort C (50 µg) to cohort D (100 µg). The last vaccination of the last subject occurred in September 2017.ConclusionThis was the first placental malaria vaccine phase Ia/b clinical trial conducted in France and Burkina Faso. No serious adverse events have been recorded. Preliminary safety and immunogenicity results will be presented.

SPf66 malaria vaccine trial: An update

1994 ◽  
Vol 10 (2) ◽  
pp. 79
Author(s):  
Marcel Tanner ◽  
Thomas Teuscher ◽  
Pedro L. Alonso
Keyword(s):  
Malaria Vaccine ◽  
Vaccine Trial

Contribution of influenza immunity and virosomal-formulated synthetic peptide to cellular immune responses in a phase I subunit malaria vaccine trial

2008 ◽  
Vol 127 (2) ◽  
pp. 188-197 ◽  
Author(s):  
Elisabetta Peduzzi ◽  
Nicole Westerfeld ◽  
Rinaldo Zurbriggen ◽  
Gerd Pluschke ◽  
Claudia A. Daubenberger
Keyword(s):  
Immune Responses ◽  
Phase I ◽  
Synthetic Peptide ◽  
Malaria Vaccine ◽  
Vaccine Trial ◽  
Cellular Immune Responses ◽  
Cellular Immune

scholarly journals Assessment of Chimpanzee Adenovirus Serotype 63 Neutralizing Antibodies Prior to Evaluation of a Candidate Malaria Vaccine Regimen Based on Viral Vectors

2014 ◽  
Vol 21 (6) ◽  
pp. 901-903 ◽  
Author(s):  
Issa Nébié ◽  
Nick J. Edwards ◽  
Alfred B. Tiono ◽  
Katie J. Ewer ◽  
Guillaume S. Sanou ◽  
...  
Keyword(s):  
Neutralizing Antibodies ◽  
Viral Vectors ◽  
Malaria Vaccine ◽  
Vaccine Trial ◽  
Neutralizing Antibody ◽  
Adenovirus Serotype ◽  
Candidate Malaria Vaccine ◽  
Antibody Titers ◽  
Adults And Children ◽  
Potential Use

ABSTRACTPrior to a chimpanzee adenovirus-based (ChAd63) malarial vaccine trial, sera were collected to assess ChAd63-specific neutralizing antibody titers in Banfora (Burkina Faso). The low neutralizing antibody titers reported in both adults and children (median titers, 139.1 and 35.0, respectively) are encouraging for the potential use of ChAd63 as a malarial vaccine vector.

The Ethics of Health Care Delivery in a Pediatric Malaria Vaccine Trial: The Perspectives of Stakeholders From Ghana and Tanzania

2017 ◽  
Vol 13 (1) ◽  
pp. 26-41 ◽  
Author(s):  
Claire Leonie Ward ◽  
David Shaw ◽  
Evelyn Anane-Sarpong ◽  
Osman Sankoh ◽  
Marcel Tanner ◽  
...  
Keyword(s):  
Health Care ◽  
Health Care Services ◽  
Malaria Vaccine ◽  
Ethical Issues ◽  
Care Delivery ◽  
Vaccine Trial ◽  
Standards Of Care ◽  
Care Services ◽  
Key Informant ◽  
Undue Inducement

This study explores ethical issues raised in providing medical care to participants and communities of low-resource settings involved in a Phase II/III pediatric malaria vaccine trial (PMVT). We conducted 52 key informant interviews with major stakeholders of an international multi-center PMVT (GSK/PATH-MVI RTS,S) (NCT00866619) in Ghana and Tanzania. Based on their stakeholder experiences, the responses fell into three main themes: (a) undue inducement, (b) community disparities, and (c) broad therapeutic misconceptions. The study identified the critical ethical aspects, from the perspectives of stakeholders, of delivering health care during a PMVT. The study showed that integrating research into health care services needs to be addressed in a manner that upholds the favorable risk–benefit ratio of research and attends to the health needs of local populations. The implementation of research should aim to improve local standards of care through building a collaborative agenda with local institutions and systems of health.

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